Presented by: Joscelyn Bowersock, Customer Success Manager, L7 Informatics Part 1 – The Change Control System• Why is a change control system needed?• When does the change control system need to be implemented?• Project change control versus quality change control• Review an example of generic change control process flow• Paper versus electronic change control systems […]

Presented by: Cheryl Bondurant, Principal Consultant, CAI In 5 years, 10 years from now what will the Biotech industry look like? What will the expectations be for the health and safety of our public … and how can our Quality Systems affect this? In this session you will learn how we can make our Quality […]

Presented by: David Shenberger, Vice President, Consulting Services, CAI This session will start off by addressing what speed to patient really means and how important operational readiness is to deliver high-quality medicines in a timely manner. We’ll take a quick look at how all the workstreams come together to deliver products. And then, we’ll dig […]

Presented by: Ravi Samavedam, Chief Innovation Officer (CINO), Azzur Group With more than 400 registered gene therapy clinical trials worldwide and a compound annual growth rate of more than 25% since 2015, there is no doubting the impact of cell and gene therapy (CGT) innovation on the market. In fact, the industry is expected to […]

Presented by: Joseph Micsko, Global Director, Process Manufacturing Technology (PMT), CAIStephen Sanders, Senior Engineer/Project Manager, CAI The pressure on ATMP companies to contain costs or avoid schedule delays has never been greater. Faced with increased urgency to bring products to patients, industry must embrace a new paradigm. During this webinar, you will understand how Quality […]